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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOTAL JOINT ORTHOPEDICS, INC. KLASSIC® FEMUR WITH COBALT 3D, SIZE 6; KNEE FEMUR
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TOTAL JOINT ORTHOPEDICS, INC. KLASSIC® FEMUR WITH COBALT 3D, SIZE 6; KNEE FEMUR Back to Search Results
Model Number 5106.06.000
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  malfunction  
Event Description
It was reported in a total knee arthroplasty case, upon opening and inspection of the packaging per the ifu, it was noticed that the inner packaging of a knee femur was damaged, the implant was not opened or used in surgery.A second identical implant was inspected and opened without report of issue.Surgery was performed, without any delay, there was no impact to the patient.
 
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Brand Name
KLASSIC® FEMUR WITH COBALT 3D, SIZE 6
Type of Device
KNEE FEMUR
Manufacturer (Section D)
TOTAL JOINT ORTHOPEDICS, INC.
1567 e stratford avenue
salt lake city UT 84106
Manufacturer Contact
bobbi siddoway
1567 e stratford avenue
sale lake city, UT 84106
8014866070
MDR Report Key13635011
MDR Text Key286344084
Report Number3008544874-2022-00003
Device Sequence Number1
Product Code MBH
UDI-Device Identifier00814703016752
UDI-Public00814703016752
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162256
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5106.06.000
Device Catalogue Number5106.06.000
Device Lot NumberQ210415-7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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